Covering the whole development process for the global biotechnology industry

Bioprocessing begins upstream, most often with culturing of animal or microbial cells in a range of vessel types (such as bags or stirred tanks) using different controlled feeding, aerating, and process strategies.

Beginning with harvest of material from a bioreactor, downstream processing removes or reduces contaminants to acceptable levels through several steps that typically include centrifugation, filtration, and/or chromatographic technologies.

Drug products combine active pharmaceutical ingredients with excipients in a final formulation for delivery to patients in liquid or lyophilized (freeze-dried) packaged forms — with the latter requiring reconstitution in the clinical setting.

Many technologies are used to characterize biological products, manufacturing processes, and raw materials. The number of options and applications is growing every day — with quality by design (QbD) giving impetus to this expansion.

Even as it matures, the biopharmaceutical industry is still a highly entrepreneurial one. Partnerships of many kinds — from outsourcing to licensing agreements to consultancies — help companies navigate this increasingly global business environment.

Saint-Gobain Performance Plastics’ Life Sciences Division is celebrating its move into the fast-growing cell therapy market with a new state-of-the-art facility that will manufacture specialty disposables for both the cell therapy and biotechnology markets. With material technology combined with expertise in custom design, Saint-Gobain Performance Plastics is uniquely positioned to offer solutions to the numerous challenges faced by cell therapy manufacturers today, contributing to the end goal of delivering effective therapies to more patients.

Located in Gaithersburg, Maryland, the new plant offers a wide variety of capabilities focused on the design, development and manufacture of single-use systems. At a ceremony in October, Saint-Gobain marked the grand opening of the facility with tours and a ribbon-cutting attended by company executives, employees, customers, suppliers and local dignitaries. Guests included Compagnie de Saint-Gobain CEO Pierre-Andre de Chalendar, Saint-Gobain Performance Plastics President Tom Kinisky, and Gaithersburg Mayor Jud Ashman.

The new manufacturing site strengthens Saint-Gobain’s position as a custom solutions provider of single-use systems while putting the company on the map in the fast-growing cell therapy market — a promising class of therapies that leverage the use of cells, often from the patients themselves, for the treatment degenerative disorders, cancers, and infectious diseases.

“Saint-Gobain’s mission is to use materials technologies to improve daily life,” said Tom Kinisky, President of Saint-Gobain Performance Plastics. “There is no better illustration of our commitment to that mission than this investment, designed to facilitate the success of individualized cell therapies, which we expect will have a great impact on generations to come.”

The company renovated a 37,000-square-foot building located at 50 W. Watkins Mill Road in Gaithersburg, Maryland, transforming it into a world-class manufacturing site that includes room for future expansion.

“This new facility will enable us to help our customers meet the challenge of scaling up the manufacturing of fully personalized therapies,” said Benjamin Le Quéré, Business Unit Manager for Saint-Gobain Bioprocess Solutions. “Through our materials science expertise as well as our deep experience in bringing manufacturing technologies to scale, Saint-Gobain is poised to help our customers and partners succeed in this quest.”

Designed following the principles of aseptic processing to minimize contaminants, the manufacturing space features state-of-the-art ISO 7 cleanrooms as well as ISO 5 assembly stations. The site also features automated environmental controls and its own monitoring capabilities.

The Gaithersburg site offers a wide variety of capabilities focused on the design, development and manufacture of single-use systems:
• Plastic injection molding and over-molding with automated part retrieval and conveyance in an ISO 7 cleanroom, using state-of-the-art molding presses including a 1,900-ton press
• ISO 5 and ISO 7 assembly spaces
• Bag manufacturing in an ISO 7 cleanroom using a proprietary laser welding process
• Engineering lab for prototyping and development of custom products